NDC 76151-207 Restorative Day Moisture Spf 15

Octinoxate, Avobenzone

NDC Product Code 76151-207

NDC 76151-207-01

Package Description: 30 mL in 1 JAR

NDC Product Information

Restorative Day Moisture Spf 15 with NDC 76151-207 is a a human over the counter drug product labeled by Boscia Llc. The generic name of Restorative Day Moisture Spf 15 is octinoxate, avobenzone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Boscia Llc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Restorative Day Moisture Spf 15 Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • OCTINOXATE 50 mg/mL
  • AVOBENZONE 30 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)
  • RICE BRAN OIL (UNII: LZO6K1506A)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • STEARETH-2 (UNII: V56DFE46J5)
  • STEARETH-21 (UNII: 53J3F32P58)
  • PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)
  • PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
  • SQUALANE (UNII: GW89575KF9)
  • PANAX GINSENG FLOWER (UNII: 3V5S2B524J)
  • CENTELLA ASIATICA (UNII: 7M867G6T1U)
  • LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
  • MAGNOLIA OBOVATA BARK (UNII: SM9Z2LD5TK)
  • MALVA SYLVESTRIS FLOWER (UNII: 12X9JI52BS)
  • MORUS ALBA ROOT (UNII: CST1G9BZGD)
  • EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • BARIUM SULFATE (UNII: 25BB7EKE2E)
  • ALANYL GLUTAMINE (UNII: U5JDO2770Z)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • BENTONITE (UNII: A3N5ZCN45C)
  • XANTHAN GUM (UNII: TTV12P4NEE)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Boscia Llc
Labeler Code: 76151
FDA Application Number: part352 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 04-16-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Restorative Day Moisture Spf 15 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Active Ingredients       Purpose


Octinoxate 5%           Sunscreen


Avobenzone 3%        Sunscreen

Otc - Purpose

Use Helps prevent sunburn.

Warnings

Warnings For external use only. Use as directed.

Otc - When Using

Avoid direct contact with eyes. If contact occurs, rinse gently with water.

Otc - Stop Use

Discontinue use and consult a physician immediately if any adverse reaction occurs.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Other Safety Information

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions  Apply in AM to cleansed and toned face.

Inactive Ingredient

Inactive Ingredients: Water, Dimethicone, Glycerin, Butylene Glycol, C12-15 Alkyl Lactate, Pentylene Glycol, Cyclopentasiloxane, Rosa Centifolia Flower Water, Oryza Sativa (Rice) Bran Oil, Glyceryl Stearate, Aloe Barbadensis Leaf Juice, Steareth-2, Steareth-21, Maltooligosyl Glucoside, Hydrogenated Starch Hydrolysate, Polysilicone-11, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, Amino Butyric Acid, Squalane, Panax Ginseng Extract, Portulace Oleracea Extract, Centella Asiatica Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Lenicera Caprifolium (Honeysuckle) Flower Extract, Magnolia Obovata Bark Extract, Malva Sylvestris (Mallow) Flower Extract, Morus Alba Root Extract, Simmondsia Chinensis (Jojoba) Leaf Extract, Epilobium Angustifolium Flower/Leaf/Stem Extract, Ricinus Communis (Castor) Seed Oil, Barium Sulfate, Alanyl Glutamine, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polysorbate 20, Stearic Acid, Polysorbate 60, Cetyl Ricinoleate, Silica, Bentonite, Carbomer, Xanthan Gum.

Description

Preservative-free. Dermatologist tested.  Alcohol-free, pH balanced, 100% natural fragrance and color, no animal testing and no animal ingredients.  www.boscia.net  B207-01  Distributed by  boscia, LLC. Irvine, CA 92614  Made in U.S.A.  U8-2

* Please review the disclaimer below.